BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 7362053 · Received March 22, 2018

    Report

    Report Number
    8010042-2018-00156
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Report Date
    April 18, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4).

    Additional Manufacturer Narrative · 0

    THE VENTILATOR WAS INVESTIGATED BY OUR FIELD SERVICE ENGINEER (FSE). THE REPORTED EVENT COULD NOT BE REPRODUCED. THE VENTILATOR WAS TESTED, PASSED PRE-USE CHECK AND WAS CLEARED FOR CLINICAL USE. NO PARTS WERE REPLACED. PROVIDED VENTILATOR LOGS WERE REVIEWED. ALARMS FOR HIGH PEEP WERE GENERATED IN COMBINATION WITH HIGH AIRWAY PRESSURE, LOW EXPIRATORY MINUTE VOLUME AND HIGH RESPIRATORY RATE ALARMS. THE GENERATED ALARMS INDICATE A HIGH EXPIRATORY RESISTANCE. AT HIGH EXPIRATORY RESISTANCE, THE PATIENT DOES NOT HAVE TIME TO BREATHE PROPERLY DURING THE EXPIRATORY PHASE BEFORE A NEW BREATH IS INITIATED. THIS LEADS TO A HIGHER PEEP VALUE THAN THE PRE-SET AND AN ALARM FOR HIGH AIRWAY PRESSURE IS GENERATED. THE DIFFICULTIES MAY EITHER BE DUE TO NON-OPTIMAL USER SETTINGS OF THE DEVICE FOR THE ACTUAL PATIENT OR AN INCREASED EXPIRATORY RESISTANCE DUE TO ACCESSORIES IN THE PATIENT CIRCUIT. INFORMATION CONCERNING WHAT TYPE OF PATIENT BREATHING CIRCUIT OR FILTER THAT WAS IN USE AT THE TIME OF EVENT WAS NOT PROVIDED. THE TECHNICAL LOG DID NOT CONTAIN ANY TECHNICAL ERROR CODES THAT COULD INDICATE A MALFUNCTION OF THE VENTILATOR. SUCCESSFUL PRE-USE CHECK WAS PERFORMED AFTER THE EVENT. THE CAUSE OF THE REPORTED PROBLEM IS ATTRIBUTED TO USER ERROR OR CLINICAL APPLICATION ERROR. THERE IS NO INDICATION OF A VENTILATOR MALFUNCTION AT THE TIME OF THE EVENT.GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE VENTILATOR WAS CONNECTED TO A PATIENT, THE PEEP (POSITIVE END EXPIRATORY PRESSURE) VALUE INCREASED TO ABOVE OF THE SET VALUE. THERE WAS NO PATIENT HARM. IMPORTER REF. #: (B)(4). MANUFACTURER REF. #: (B)(4).

    Description of Event or Problem · 0

    IMPORTER REF. #: (B)(4). MANUFACTURER REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203815 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1